The Effect of Diaphragmatic Respiratory Exercise Training on Clinical Symptoms, Quality of Life and Referral to physician in The Gastro-esophageal Reflux Patients (GERD)
Determining the effect of diaphragmatic breathing training on clinical symptoms, quality of life and re-seeing a physician in patients with gastroesophageal reflux disease
Design
patients will be randomly assigned to one of the intervention or control groups based on a table of random numbers. no intervention will be done in the control group and diaphragmatic breathing exercises will be taught and performed in the intervention group. The sample of the present study is based on the sample size formula of 146 people.
Settings and conduct
In this study, the research community included patients with GERD in the gastrointestinal clinic of Shariati Hospital affiliated to Tehran University of Medical Sciences.The purpose of diaphragmatic breathing exercises in this study is to change chest breathing to abdominal breathing along with contraction of the patient's diaphragmatic muscles. The educational content in the form of a booklet will also be provided to patients at the end of the training.
Participants/Inclusion and exclusion criteria
Entry Criteria: In this study, patients with gastroesophageal reflux disease will enter the study with grade 2 esophagus, a tendency to participate in the study and age 20-60 years.
Criteria for not entering the study:
There is another chronic disease that affects the quality of life, Pregnancy, History of upper gastrointestinal surgery, BMI above 35 and below 18
Dissatisfaction with studying.
Intervention groups
No intervention will be performed in the control group and diaphragmatic breathing exercises will be taught and performed in the intervention group.
Main outcome variables
Prerequisite: Recurrence, quality of life and clinical signs that will be measured before, one month later and six months later with the above questionnaires. Secondary outcome: frequency of symptoms and duration of symptoms
General information
Reason for update
Acronym
GERD
IRCT registration information
IRCT registration number:IRCT20190727044341N2
Registration date:2020-05-01, 1399/02/12
Registration timing:prospective
Last update:2020-05-01, 1399/02/12
Update count:0
Registration date
2020-05-01, 1399/02/12
Registrant information
Name
Amin Hosseini Sooreh Bargh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7701 1942
Email address
ahosseinis@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-21, 1399/05/31
Expected recruitment end date
2022-02-28, 1400/12/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Diaphragmatic Respiratory Exercise Training on Clinical Symptoms, Quality of Life and Referral to physician in The Gastro-esophageal Reflux Patients (GERD)
Public title
The Effect of Diaphragmatic Respiratory Exercise Training on Clinical Symptoms, Quality of Life and Referral to physician in The Gastro-esophageal Reflux Patients (GERD)
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Criteria for entering the study: Patients with second-degree gastroesophageal reflux disease who need medication in addition to lifestyle changes.
The desire to participate in the study
Age 20-60
Exclusion criteria:
Criteria for not entering the study: the presence of other chronic diseases that affect quality of life (cardiovascular disease, chronic kidney disease, chronic obstructive pulmonary disease, cirrhosis, rheumatoid disease, a history of malignancy, scleroderma, diabetes and a history of stroke Brain)
Pregnancy
History of upper gastrointestinal surgery
BMI above 35 and below 18
Dissatisfaction with studying
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
146
Randomization (investigator's opinion)
Randomized
Randomization description
After the pre-test, patients will be randomly assigned to one of the intervention or control groups based on a table of random numbers. For this purpose, a list of patients with entry criteria will be prepared and no intervention will be done in the control group and diaphragmatic breathing exercises will be taught and performed in the intervention group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-Chancellor in Research Affairs- Tehran University of Medical Sciences
Street address
Deputy of Research and Technology, sixth floor, Central University Organization, corner of Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
81633698
Approval date
2020-04-11, 1399/01/23
Ethics committee reference number
IR.TUMS.VCR.REC.1399.249
Health conditions studied
1
Description of health condition studied
Gastro-esophageal reflux disease
ICD-10 code
K21
ICD-10 code description
Gastro-esophageal reflux disease
Primary outcomes
1
Description
Clinical Symptoms: In this study, clinical symptoms will be measured using the Reflux Disease (RDQ) questionnaire. The Reflux Disease (RDQ) questionnaire includes questions about heartburn, regurgitation, and dyspnea based on the frequency and severity of symptoms. The scores of each question are in the Likert range from zero to five for the frequency and severity of the symptoms, and the higher the score of the questionnaire, the greater the severity of the symptoms or the greater the frequency of symptoms.
Timepoint
Before the study, one and six months later
Method of measurement
Reflux Disease Questionnaire (RDQ)
2
Description
Quality of life: In this study, GERD-HRQL questionnaire is used to measure this variable. This questionnaire includes ten questions about the symptoms of the disease from 0 (asymptomatic) to 5 (inability to perform daily activities). The score from these ten questions ranges from zero (best) to 45 (worst).
Timepoint
Before the study, one and six months later
Method of measurement
GERD-HRQL Questionnaire
3
Description
Re-visit to the doctor: In this study, re-referral to the doctor will be reported using patients' self-report after the intervention and follow-up.
Timepoint
Before the study, one and six months later
Method of measurement
Self-report
Secondary outcomes
empty
Intervention groups
1
Description
Control group: No intervention will be made in this group.
Category
N/A
2
Description
Intervention group: Diaphragmatic breathing exercises will be taught and performed in the intervention group. The purpose of diaphragmatic breathing exercises in this study is to change chest breathing to abdominal breathing along with contraction of the patient's diaphragmatic muscles. The training includes the following: Explaining the purpose of diaphragmatic breathing exercises to the patient - The patient will be asked to be in an open position and place one hand on the chest and the other hand above the navel in the abdomen. - Teach the patient He will be able to breathe through the nose and exhale with his mouth open while only the abdomen moving up and down (the goal is for the abdomen to go up and down, while the shoulders and chest without The patient will be taught to perform the tail operation slowly by counting the numbers one to four and the exhalation operation by counting the numbers five to eight slowly. do it. If the patient has difficulty breathing, he or she will be taught how to breathe with the help of inhaled lips. Sit down and then stand up. The patient will be instructed to do the exercises three times a day, 30 breaths or five minutes at home each time.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Dr. Saeed Reza Mehrpour
Street address
Dr. Shariati Research and Medical Training Center, in front of the Faculty of Economics, Jalal Al-Ahmad Highway, North Kargar St, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 0008 4901
Fax
+98 21 8863 3039
Email
shariatihosp@tums.ac.ir
Web page address
http://shariati.tums.ac.ir/Show/Item/2
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraeian
Street address
Deputy of Research and Technology, sixth floor, Central University Organization, corner of Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
81633686
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amin Hosseini Sooreh Bargh
Position
Master of Medical surgical Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of nursing and midwifery, Tohid square, Tehran
City
Tehtan
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
aminhosseini835@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amin Hosseini Sooreh Bargh
Position
Master of Medical surgical Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of nursing and midwifery, Tohid square, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
aminhosseini835@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amin Hosseini Sooreh Bargh
Position
Master of medical surgical Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of nursing and midwifery, Tohid square, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
aminhosseini835@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available